PHILADELPHIA, September 16, 2008 – A panel of leading breast cancer experts has
identified and prioritized 13 late-stage, or Phase 3, breast cancer research
studies from a total of more than 515 currently underway, with the greatest
potential to improve treatment and survival.
The 21 experts, all members of the Coalition of Cancer
Cooperative Group’s Scientific Leadership Council (SLC) in Breast Cancer
outlined their consensus -- Research Priorities in Breast Cancer:
Recommendations of the Scientific Leadership Council in Breast Cancer of the
Coalition of Cancer Cooperative Groups -- at a meeting of physicians,
researchers, patient advocates, government and industry representatives in
Dallas September 12-13, and urged physicians to enroll as many of their
eligible patients into the trials as possible. The SLC in Breast Cancer was
chaired by Julie Gralow, MD, associate professor, University of Washington
School of Medicine, and Director, Breast Medical Oncology at UW’s Seattle
Cancer Care Alliance and Edith Perez, MD, Director of the Breast Cancer
Program, Division of Hematology/Oncology, and Department of Internal Medicine
at the Mayo Clinic in Jacksonville, Florida.
Together, the priority studies require patient enrollment of
nearly 43,500. To date, about 17,400 patients have been enrolled, leaving more
than 26,000 patients still needed for these studies. Enrollment of breast
cancer patients in publicly funded studies averages about 9,300 annuallyi;
the number of breast cancer patients on privately funded studies is not known.
More rapid enrollment and timely completion of these studies can quicken the
pace of diagnostic and treatment advances by resolving clinical questions such
How to predict the impact of biological effects of chemopreventive agents with
the development and validation of new, clinically relevant biomarkers
How to design, select – and afford - individualized cancer therapy in an era of
escalating costs for biologic treatments
How, when and whether to use chemotherapy in breast cancer treatment for some
How to best incorporate novel approaches, including biophosphonates in breast
cancer treatment to reduce the risk of bone metastases
How best to address the growing issue of long term neurotoxic and cognitive
side effects in breast cancer survivors
How to design clinical trials that can be completed more efficiently including
randomized discontinuation trials or "adaptive" trial designs that require
fewer patients and/or shorter study duration.
Six of the studies are for patients with early-stage breast
cancer, three are studies investigating the use of drugs to shrink tumors or
eliminate cancer cells prior to surgery, two are in advanced breast cancer, one
focuses on quality of life, and one on effectiveness of partial over whole
breast irradiation. A molecular/genetic profiling study will determine whether
some women typically treated with chemotherapy in addition to hormonal therapy
based on clinical characteristics may not need chemotherapy.
Breast cancer remains the most common malignancy in women in the
U.S. and is the second most common cause of cancer death. In 2008, it is
estimated that 182,460 new cases of invasive and 67,770 cases of in situ breast
cancer will be diagnosed in women and 40,480 women will die from the disease.
The SLC also emphasized the importance of connecting patients to
priority trial information. Research conducted by the Coalition and
Northwestern University shows that only 15 percent of all breast cancer
patients are aware of the clinical trial option at time of diagnosis. The
Coalition’s TrialCheck®, Internet-based cancer clinical trial navigation and
matching system of all federally registered cancer studies, is designed to help
close this information gap by electronically linking patients to hospitals and
practices near their home offering cancer clinical trials relevant to the
patient’s individual medical needs.
Coalition of Cancer Cooperative Groups
1818 Market Street, Suite 1100, Philadelphia, PA 19103 (215) 789-3600
iBaseline Study of Patient Accrual onto Publicly Sponsored US Cancer
Clinical Trials: An Analysis Conducted for the Global Access Project of the
National Patient Advocate Foundation. Coalition of Cancer Cooperative Groups,
Philadelphia, PA. February 1, 2006 (Study Period: 01/01/03 – 06/30/05).